Dear Sushma, the Israeli medical device new applications form is also used for change request and renewals (attached). It's in Hebrew too, so you will need assistance in completing it (it seems to be a pdf e-form).
The following are mentioned in this form so I would consider them as "changes": manufacture name, address (i.e., manufacturing site). The logo is not specified.
I agree with Sharon that using a local contact in Israel is the best strategy, since you might receive a response or request for additional information.
Warm regards,
Hagar
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Hagar Sachs
Tel Aviv
Israel
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Original Message:
Sent: 01-Apr-2024 16:20
From: Sushma Polisetty
Subject: Israel change related regulatory requirements_Medical Device
Already marketed in Israel MEDICAL DEVICE, IN THIS CASE.
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Sushma Polisetty
Lead Consultant
Bengaluru
India
Original Message:
Sent: 28-Mar-2024 10:15
From: Sharon Shachar
Subject: Israel change related regulatory requirements_Medical Device
Hi Sushma,
Is your product already placed on the market in Israel ? or do you plan to register a new product?
The guidance for registration can be found in the Ministry of health website in the following link, but I doubt it will be useful for non-Israelis since it is written in Hebrew.
https://www.gov.il/BlobFolder/dynamiccollectorresultitem/amr-guidelines_amr_reg_guidelines/he/units_amar_AMR_reg_guidelines.pdf
My advice to you is to find a local contact in Israel, maybe your distributor, to help you complete the registration.
Hope it helps,
Sharon
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Sharon Shachar
Regulatory Specialist
Terumo BCT Inc. - ENTERPRISE
Cedar Park TX
United States
Original Message:
Sent: 27-Mar-2024 01:27
From: Sushma Polisetty
Subject: Israel change related regulatory requirements_Medical Device
Hi members of RAPS,
I am not able to find much information on change related regulatory requirements for medical devices in Israel, need help to find below information-
- Change in manufacture name if happens for foreign manufacturer
- Change in manufacturing site for foreign manufacturer
- Change in Logo of company
- Note-I could find on transfer of registration and LRP change info. but not above ones, please help.
- Is there any documents specifically devoted for medical device change related regulation for approved products?
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Sushma Polisetty
Lead Consultant
Bengaluru
India
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